Recruiting
Phase 2

FUS

Sponsor:

VA Office of Research and Development

Code:

NCT06820138

Conditions

Posttraumatic Stress Disorder

Eligibility Criteria

Sex: All

Age: 22 - 70

Healthy Volunteers: Not accepted

Interventions

Brainsonix Ultrasound Device

Study Details

Brief summary:

The goal of this study is to develop a new, non-invasive brain stimulation modality called low intensity focused ultrasound (FUS) as a psychiatric rehabilitation treatment for posttraumatic stress disorder (PTSD). FUS delivers energy comparable to that involved in diagnostic ultrasound but in a millimeter-sized envelope. Unlike currently available methods, the maximal FUS energy is delivered at a distance from a transducer on the scalp. Therefore, its promise is that it can deliver focal and reversible modulation to deeper brain regions involved in PTSD. The investigator team has previously conducted first-in-human research in FUS, and this study builds upon that work to conduct a phase II, dose-finding study. This study will pursue two Aims; the first is whether FUS to the amygdala can improve symptoms, and the second will evaluate whether FUS improves function by reduced disability, over a 1-month period. Short and longer-term effects of FUS will be measured and all FUS parameters are within FDA-defined safety thresholds for diagnostic ultrasound.

Conditions

Posttraumatic Stress Disorder

Study ID

NCT06820138

Start date

Sep 9, 2026

Status verified date

Sep, 2026

Completion date

Mar 29, 2030

Anticipated

Primary completion date

Dec 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

-Veterans ages who meet DSM-5 criteria for chronic Post-traumatic stress disorder (PTSD) using the Clinician Administered PTSD Scale for DSM-5 (CAPS-5) and currently symptomatic. If applicable, Veterans will be required to be on stable psychiatric treatment(s) prior to baseline assessments

Exclusion Criteria:

  • contraindications to focused ultrasound and/or neuroimaging:

  • i) history of seizure disorder or serious neurologic illness including dementia or serious cognitive impairment,
  • ii) structural or neurologic abnormalities present or in close proximity to sonication site
  • iii) prior brain surgery
  • iv) pacemaker or implanted central nervous system device
  • v) greater than mild traumatic brain injury, or any head injury within sixty days of ultrasound
  • vi) greater than moderate alcohol or substance use disorders or active use or withdrawal from alcohol or substances
  • vii) metal in the head
  • viii) physical impediment likely to interfere with assessments, or
  • ix) unable to follow protocols
  • x) Veterans with significant white matter findings or those with findings in the beam of the ultrasound may also be excluded at discretion of study staff
  • Veterans with acute suicidality are also excluded

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Verum low intensity focused ultrasound

Verum (active) low intensity focused ultrasound, applied up to three times per week.

sham comparator: Sham low intensity focused ultrasound

Sham (inactive) low intensity focused ultrasound, applied up to three times per week.

Interventions

Brainsonix Ultrasound Device

This device delivers low intensity focused ultrasound and delivers either active or sham sonication depending upon the transducer pad used.

Primary outcome measure

  • Post-traumatic stress disorder (PTSD) Checklist for DSM5 [ Time Frame: Up to 3 months ]

Central Contacts and Locations

Central contacts

Noah S Philip, MD

(401) 273-7100noah.philip@va.gov

Alison Gorbatov

(401) 271-7100Alison.Gorbatov@va.gov

Locations

Providence VA Medical Center, Providence, RI

Recruiting

Providence, Rhode Island, United States, 02908-4734

Contacts

Kate J Barnabe, MHA

(401) 273-7100Kate.Barnabe@va.gov

Amy Mochel

Amy.Mochel@va.gov

Principal Investigator:

Noah S. Philip, MD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Sep 15, 2026

Last verified

Sep, 2026

Keywords

  • Low intensity focused ultrasound

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-16. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-09-15.